ID

10027

Beschrijving

CALGB: 40101 FOLLOW-UP FORM Four Versus Six Cycles of Cyclophosphamide/Doxorubicin or Paclitaxel in Adjuvant Breast Cancer NCT00041119 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A46CA742-FE60-27F9-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A46CA742-FE60-27F9-E034-080020C9C0E0

Trefwoorden

Versies (2)
  1. 26-08-12 26-08-12 -
  2. 19-03-15 19-03-15 - Martin Dugas
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19 maart 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer adjuvant therapy (CALGB 40101 NCT00041119)

Engels

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Circle amended items and check "Amended data" box to the right. If submitting by mail, retain a copy for your records and send the original to the CALGB Statistical Center, Data Operations. If faxing, use an original form for maximum clarity in transmission and fax to 919-416-4990. If submitting electronically, click the Send button when you have completed the PDF version of the form.

1 Formulieren  
Header
Beschrijving

Header

CALGB Form
Beschrijving

CALGBForm

Datatype

text

CALGB Study No
Beschrijving

CALGBStudyNo

Datatype

text

CALGB Patient ID
Beschrijving

CALGBPatientID

Datatype

text

From
Beschrijving

From

Datatype

text

To (date of last contact or death)
Beschrijving

To

Datatype

text

Amended data?
Beschrijving

Amended data?

Datatype

boolean

Patient's Name
Beschrijving

Patient'sName

Datatype

text

Participating Group
Beschrijving

ParticipatingGroup

Datatype

text

Alias
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Hospital Number
Beschrijving

PatientHospitalNumber

Datatype

text

Participating Group Protocol No.
Beschrijving

ParticipatingGroupProtocolNo.

Datatype

text

Main Member Institution/Adjunct
Beschrijving

MainMemberInstitution/Adjunct

Datatype

text

Participating Group Patient No.
Beschrijving

ParticipatingGroupPatientNo.

Datatype

text

Completed By (Print or Type Name)
Beschrijving

CompletedBy

Datatype

text

Date Completed (M)
Beschrijving

DateCompleted

Datatype

date

Comments
Beschrijving

Comments

Datatype

text

Patient status
Beschrijving

Patient status

Patient's Vital Status (mark one with an X)
Beschrijving

Patient's Vital Status (mark one with an X)

Datatype

text

Cause of death (if dead)
Beschrijving

Cause of death (if dead)

Datatype

text

Alias
UMLS CUI-1
C0007465
Describe cause of death (Disease Assessment)
Beschrijving

DeathReason,Specify

Datatype

text

Current Menopausal Status (If premenopausal prior to chemotherapy mark one with an X)
Beschrijving

CurrentMenopausalStatus

Datatype

text

Resumption date
Beschrijving

Resumptiondate

Datatype

text

Cessation date (M)
Beschrijving

Cessationdate

Datatype

text

Has patient had a documented clinical assessment for this cancer since submission of the previous follow-up form?
Beschrijving

Haspatienthadadocumentedclinicalassessmentforthiscancersincesubmissionofthepreviousfollow-upform?

Datatype

boolean

Date of last clinical assessment (M)
Beschrijving

CancerFollow-upStatusDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Has the patient been diagnosed with a first local-regional recurrence/progression since submission of the last follow-up form?
Beschrijving

Hasthepatientbeendiagnosedwithafirstlocal-regionalrecurrence/progressionsincesubmissionofthelastfollow-upform?

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25180
Date of first local-regional progression (M)
Beschrijving

ProgressionDate,FirstLocal-Regional

Datatype

date

Site(s) of first local-regional progression (mark all that apply with an X)
Beschrijving

ProgressionSite(s),FirstLocal-Regional

Datatype

text

How was this progression information obtained? (mark one with an X)
Beschrijving

ProgressionAssessmentSource

Datatype

text

Has the patient been diagnosed with a first distant recurrence/progression since submission of the last follow-up form?
Beschrijving

Hasthepatientbeendiagnosedwithafirstdistantrecurrence/progressionsincesubmissionofthelastfollow-upform?

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1269798
Date of first distant progression (M)
Beschrijving

ProgressionDate,FirstDistant

Datatype

date

Site(s) of first distant progression
Beschrijving

ProgressionSite,FirstDistant

Datatype

text

Has a new primary cancer or myelodysplastic syndrome (MDS) been diagnosed that has not been previously reported?
Beschrijving

Hasanewprimarycancerormyelodysplasticsyndrome(MDS)beendiagnosedthathasnotbeenpreviouslyreported?

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25180
Date of diagnosis (M)
Beschrijving

Date of diagnosis (M)

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
Site(s) of New Primary (If new primary site is AML/MDS, submit NCI AML/MDS form. All other new primaries must be reported using the MEDWATCH form C-804. Submit to CALGB Central Office)
Beschrijving

NewPrimarySite

Datatype

text

Adverse event
Beschrijving

Adverse event

Alias
UMLS CUI-1
C0877248
Has the patient experienced (prior to diagnosis of recurrence or second primary) any severe (Grade >= 3), long term treatment related toxicity that has not been previously reported? (Long-Term Cardiac Toxicity)
Beschrijving

Hasthepatientexperienced(priortodiagnosisofrecurrenceorsecondprimary)anysevere(Grade>=3),longtermtreatmentrelatedtoxicitythathasnotbeenpreviouslyreported?

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1519275
UMLS CUI-2
C3537125
IMT Code
Beschrijving

IMTCode

Datatype

text

CTC Adverse Event Term
Beschrijving

CTCAdverseEventTerm

Datatype

text

Grade (only 3, 4, 5)
Beschrijving

Grade

Datatype

float

Date of Onset (M)
Beschrijving

DateofOnset

Datatype

text

Therapy
Beschrijving

Therapy

Did this patient receive any tamoxifen?
Beschrijving

PastTamoxifenInd

Datatype

boolean

Is the patient still receiving tamoxifen?
Beschrijving

CurrentTamoxifenInd

Datatype

boolean

Alias
UMLS CUI-1
C0039286
Date tamoxifen started (if not previously reported)
Beschrijving

Datetamoxifenstarted

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
If patient discontinued tamoxifen since last follow-up, give date (M)
Beschrijving

TamoxifenDiscontinuedDate

Datatype

date

Did the patient receive any aromatase inhibitors?
Beschrijving

Didthepatientreceiveanyaromataseinhibitors?

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Which aromatase inhibitor? (mark one with an X)
Beschrijving

Whicharomataseinhibitor?

Datatype

text

Other, specify (aromatase inhibitor)
Beschrijving

Other,specify(aromataseinhibitor)

Datatype

text

Is the patient still receiving aromatase inhibitor?
Beschrijving

Isthepatientstillreceivingaromataseinhibitor?

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Date aromatase inhibitor started (if not previously reported)
Beschrijving

Datearomataseinhibitorstarted

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C1740
UMLS 2011AA ObjectClass-2
C0593802
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
If patient discontinued aromatase inhibitor since last follow-up, give date (M)
Beschrijving

Ifpatientdiscontinuedaromataseinhibitorsincelastfollow-up,givedate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0011008
Did patient receive non-protocol cancer therapy prior to first recurrence and not previously reported? (mark all that apply with an X)
Beschrijving

Didpatientreceivenon-protocolcancertherapypriortofirstrecurrenceandnotpreviouslyreported?

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1518384
UMLS CUI-2
C0087111
Non-Protocol Therapy
Beschrijving

Non-ProtocolTherapy

Datatype

text

Non-protocol chemotherapy, specify
Beschrijving

Non-ProtocolChemotherapyAdministeredSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass-2
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Non-protocol hormonal therapy, specify
Beschrijving

Non-ProtocolHormoneTherapyAdministeredSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass-2
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Non-protocol biologic response modifier therapy, specify
Beschrijving

Non-protocolbiologicresponsemodifiertherapy,specify

Datatype

text

Non-protocol radiation therapy, specify
Beschrijving

Non-ProtocolRadiationTherapyAdministeredSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass-2
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
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Similar models

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Circle amended items and check "Amended data" box to the right. If submitting by mail, retain a copy for your records and send the original to the CALGB Statistical Center, Data Operations. If faxing, use an original form for maximum clarity in transmission and fax to 919-416-4990. If submitting electronically, click the Send button when you have completed the PDF version of the form.

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
CALGBForm
Item
CALGB Form
text
CALGBStudyNo
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID
text
From
Item
From
text
To
Item
To (date of last contact or death)
text
Amended data
Item
Amended data?
boolean
Patient'sName
Item
Patient's Name
text
ParticipatingGroup
Item
Participating Group
text
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientHospitalNumber
Item
Patient Hospital Number
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
MainMemberInstitution/Adjunct
Item
Main Member Institution/Adjunct
text
ParticipatingGroupPatientNo.
Item
Participating Group Patient No.
text
CompletedBy
Item
Completed By (Print or Type Name)
text
DateCompleted
Item
Date Completed (M)
date
Comments
Item
Comments
text
Item Group
Item
Patient's Vital Status (mark one with an X)
text
CL.2
Code List
Patient's Vital Status (mark one with an X)
CL Item
Alive (Alive)
C2584946 (UMLS CUI-1)
CL Item
Dead (Dead)
C0011065 (UMLS CUI-1)
CL Item
Lost to Follow-Up (Lost)
C1302313 (UMLS CUI-1)
Item
Cause of death (if dead)
text
C0007465 (UMLS CUI-1)
CL.3
Code List
Cause of death (if dead)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To Other Cause (Due to other cause)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DeathReason,Specify
Item
Describe cause of death (Disease Assessment)
text
Item
Current Menopausal Status (If premenopausal prior to chemotherapy mark one with an X)
text
CL.11
Code List
Current Menopausal Status (If premenopausal prior to chemotherapy mark one with an X)
CL Item
Regular Menses Continue/resume (Regular menses continue/resume)
CL Item
Regular Menses Have Stopped (Regular menses have stopped)
Resumptiondate
Item
Resumption date
text
Cessationdate
Item
Cessation date (M)
text
Clinical assessment since previous follow-up
Item
Has patient had a documented clinical assessment for this cancer since submission of the previous follow-up form?
boolean
CancerFollow-upStatusDate
Item
Date of last clinical assessment (M)
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
First local-regional recurrence
Item
Has the patient been diagnosed with a first local-regional recurrence/progression since submission of the last follow-up form?
boolean
C25180 (NCI Thesaurus ValueDomain)
ProgressionDate,FirstLocal-Regional
Item
Date of first local-regional progression (M)
date
Item
Site(s) of first local-regional progression (mark all that apply with an X)
text
CL.6
Code List
Site(s) of first local-regional progression (mark all that apply with an X)
CL Item
Ipsilateral breast (Ipsilateral breast)
CL Item
Axillary nodes (Axillary nodes)
CL Item
Supraclavicular nodes (Supraclavicular nodes)
CL Item
Infraclavicular nodes (Infraclavicular nodes)
CL Item
Chest wall (Chest wall)
CL Item
Internal mammary nodes (Internal mammary nodes)
CL Item
Axilla (Axilla)
Item
How was this progression information obtained? (mark one with an X)
text
CL.9
Code List
How was this progression information obtained? (mark one with an X)
CL Item
Documented clinical assessment (Documented clinical assessment)
CL Item
Patient Self Report Only (Patient self report only)
Distant metastasis
Item
Has the patient been diagnosed with a first distant recurrence/progression since submission of the last follow-up form?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1269798 (UMLS CUI-1)
ProgressionDate,FirstDistant
Item
Date of first distant progression (M)
date
ProgressionSite,FirstDistant
Item
Site(s) of first distant progression
text
New primary cancer or MDS
Item
Has a new primary cancer or myelodysplastic syndrome (MDS) been diagnosed that has not been previously reported?
boolean
C25180 (NCI Thesaurus ValueDomain)
New Primary Cancer Date
Item
Date of diagnosis (M)
date
C25164 (NCI Thesaurus ValueDomain)
NewPrimarySite
Item
Site(s) of New Primary (If new primary site is AML/MDS, submit NCI AML/MDS form. All other new primaries must be reported using the MEDWATCH form C-804. Submit to CALGB Central Office)
text
Item Group
C0877248 (UMLS CUI-1)
Toxicity grade 3 or more
Item
Has the patient experienced (prior to diagnosis of recurrence or second primary) any severe (Grade >= 3), long term treatment related toxicity that has not been previously reported? (Long-Term Cardiac Toxicity)
boolean
C25180 (NCI Thesaurus ValueDomain)
C1519275 (UMLS CUI-1)
C3537125 (UMLS CUI-2)
IMTCode
Item
IMT Code
text
CTCAdverseEventTerm
Item
CTC Adverse Event Term
text
Grade
Item
Grade (only 3, 4, 5)
float
DateofOnset
Item
Date of Onset (M)
text
Item Group
PastTamoxifenInd
Item
Did this patient receive any tamoxifen?
boolean
Tamoxifen
Item
Is the patient still receiving tamoxifen?
boolean
C0039286 (UMLS CUI-1)
Datetamoxifenstarted
Item
Date tamoxifen started (if not previously reported)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
TamoxifenDiscontinuedDate
Item
If patient discontinued tamoxifen since last follow-up, give date (M)
date
Didthepatientreceiveanyaromataseinhibitors?
Item
Did the patient receive any aromatase inhibitors?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Item
Which aromatase inhibitor? (mark one with an X)
text
CL.22
Code List
Which aromatase inhibitor? (mark one with an X)
CL Item
Anastrozole (Anastrozole)
C1607 (NCI Thesaurus)
C0290882 (UMLS 2011AA)
CL Item
Letrozole (Letrozole)
C1527 (NCI Thesaurus)
C0246421 (UMLS 2011AA)
CL Item
Other, Specify (Other, specify)
Other,specify(aromataseinhibitor)
Item
Other, specify (aromatase inhibitor)
text
Isthepatientstillreceivingaromataseinhibitor?
Item
Is the patient still receiving aromatase inhibitor?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Datearomataseinhibitorstarted
Item
Date aromatase inhibitor started (if not previously reported)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C1740 (NCI Thesaurus ObjectClass-2)
C0593802 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Aromatase inhibitor end date
Item
If patient discontinued aromatase inhibitor since last follow-up, give date (M)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS CUI-1)
Non-protocol Therapy
Item
Did patient receive non-protocol cancer therapy prior to first recurrence and not previously reported? (mark all that apply with an X)
boolean
C25180 (NCI Thesaurus ValueDomain)
C1518384 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Item
Non-Protocol Therapy
text
CL.18
Code List
Non-Protocol Therapy
CL Item
Non-protocol Chemotherapy, Specify (Non-protocol chemotherapy, specify)
CL Item
Non-protocol Hormonal Therapy, Specify (Non-protocol hormonal therapy, specify)
CL Item
Non-protocol Biologic Response Modifier Therapy, Specify (Non-protocol biologic response modifier therapy, specify)
CL Item
Non-protocol Radiation Therapy, Specify (Non-protocol radiation therapy, specify)
CL Item
Non-protocol High Dose Chemotherapy/autologous Cell Transplant (Non-protocol high dose chemotherapy/autologous cell transplant)
Non-ProtocolChemotherapyAdministeredSpecify
Item
Non-protocol chemotherapy, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Non-ProtocolHormoneTherapyAdministeredSpecify
Item
Non-protocol hormonal therapy, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Non-protocolbiologicresponsemodifiertherapy,specify
Item
Non-protocol biologic response modifier therapy, specify
text
Non-ProtocolRadiationTherapyAdministeredSpecify
Item
Non-protocol radiation therapy, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
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